RegoRec: Biomolecular Analysis for Predicting Response to Regorafenib
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05759195
Collaborator
(none)
55
1
1
47.8
1.2
Study Details
Study Description
Brief Summary
The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Tumor Biomolecular Analysis for Defining Predictive Factors for Response to Regorafenib in Recurrent Glioblastoma
Actual Study Start Date
:
Jan 7, 2021
Anticipated Primary Completion Date
:
Jun 30, 2024
Anticipated Study Completion Date
:
Dec 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Biomolecular tumor analysis NGS, IHC, methylome and other molecular studies |
Diagnostic Test: Biomolecular tumor analysis
NGS analysis, other molecular analyses on FFPE tumor tissue
|
Outcome Measures
Primary Outcome Measures
- Overall survival [through study completion, an average of 3 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
recurrent glioblastoma after surgery and chemoradiation with temozolomide;
-
indication to treatment with regorafenib per standard of care;
-
written informed consent.
Exclusion Criteria:
None.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05759195
Other Study ID Numbers:
- 3458
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Additional relevant MeSH terms: